Welcome to the latest edition of Vaccines for the Future. With the new year comes exciting developments in our program, including new projects to enhance influenza vaccine production in Vietnam and to expand research and development of vaccines against diarrheal disease. We are happy to announce new Phase 1 clinical trial results from an enterotoxigenic Escherichia coli (ETEC) study and new partnerships to advance vaccine candidates against pneumococcal disease, ETEC, and Shigella. Our staff has also been busy contributing to the scientific literature, co-authoring two recently published journal articles on influenza and providing input for a book on best practices in global health that highlights one of our pneumococcal vaccine partnerships. We also emphasize in this edition the role of our scientific advisory boards, which provide valuable expertise throughout the development of our projects.

In addition, we feature several new PATH resources, including a new meningococcus section on PATH’s Vaccine Resource Library. Finally, we provide links to upcoming conferences and events of interest and job opportunities within our program. As always, we welcome your feedback and hope these updates continue to be useful.

Sincerely,
John W. Boslego, MD
Director,Vaccine Development Global Program
PATH

PATH has received an award from the Biomedical Advanced Research and Development Authority (BARDA) within the US Department of Health and Human Services to support the enhancement of sustainable influenza vaccine production in Vietnam. BARDA is providing the full US$7.9 million in funding, which builds upon support that BARDA is currently providing to the World Health Organization (WHO) to help Vietnam, and other countries, prepare for eventual licensure and commercial-scale manufacturing of influenza vaccines. PATH will collaborate with various groups in Vietnam, including the Government of Vietnam and vaccine manufacturers, to assist in the production and clinical development of safe and effective influenza vaccines. By helping Vietnam strengthen production capacity, this project will be an important step toward increasing local and regional vaccine supplies and improving real-time response in an influenza pandemic. It can also serve as a model for other efforts to build local production of influenza vaccines in developing countries.

In other news, Drs. Rick Bright and Kathleen Neuzil from PATH’s influenza vaccine project co-authored a conference report recently published in Vaccine, which summarizes the WHO meeting held in Portugal in 2008 on the role of neuraminidase in inducing protective immunity against influenza infection. The meeting set the stage for further dialogue on the topic, including a recent follow-up meeting in 2009 held in Cannes, France. Dr. Neuzil also recently co-authored an editorial in the Journal of the American Medical Association, which commented on encouraging new immunogenicity data on pandemic influenza A(H1N1) 2009 vaccines for children.

Preliminary results of a Phase 1 trial studying an oral enterotoxigenic Escherichia coli (ETEC) vaccine candidate, ACE527, show a strong safety profile and promising initial immunological data. This live, attenuated whole cell vaccine candidate, being developed by TD Vaccines (formerly ACE BioSciences), is comprised of three ETEC strains and was tested in 36 adult volunteers at two dosage levels. Complete data will be available later in 2010, but ACE527 has met the immunological criteria required to move on to a Phase 2 challenge study. PATH’s enteric vaccine project supported the trial, which was conducted at Johns Hopkins University’s Center for Immunization Research in Baltimore, Maryland.

In related news, PATH recently signed an agreement with the Division of Microbiology and Infectious Diseases, National Institutes of Allergy and Infectious Diseases, part of the US National Institutes of Health in Bethesda, Maryland, to conduct a Phase 1 clinical trial of the double mutant heat-labile toxin (dmLT) vaccine/adjuvant. The dmLT, a highly promising new vaccine/adjuvant that PATH in-licensed from Tulane University, is also an ETEC antigen that may offer protection against disease. The trial is expected to begin by mid-2010. PATH also recently signed an agreement with the Walter Reed Army Institute of Research in Silver Spring, Maryland to develop an inactivated Shigella whole cell vaccine candidate. The partnership will include manufacturing of the vaccine candidate, as well as characterization through preclinical animal studies to prepare for human clinical trials. The candidate will be tested both alone and in conjunction with the dmLT vaccine/adjuvant.

PATH’s pneumococcal vaccine project recently entered into an agreement with GlaxoSmithKline Biologicals SA (GSK), the Medical Research Council in The Gambia, and the London School of Hygiene and Tropical Medicine to support the development of GSK’s protein-plus-conjugate vaccine candidate against Streptococcus pneumoniae—a disease that kills nearly one million children each year, mostly in Africa and Asia. The vaccine candidate includes an innovative combination of protein and conjugate vaccine technologies that could lead to broad coverage across the numerous pneumococcal serotypes. Under the agreement, the partners will conduct several studies in The Gambia—first, an epidemiological study to determine nasopharyngeal carriage in infants, and then a clinical trial to evaluate the vaccine candidate’s safety and immunogenicity in toddlers and infants, including evaluation of impact on pneumococcal nasopharyngeal colonization.

Dr. Mark Alderson, director of PATH’s pneumococcal vaccine project, delivered a presentation on pneumococcal protein vaccines at the November 2009 Meningitis Research Foundation’s Meningitis and Septicaemia in Children and Adults Conference in London. The meeting brought together health experts from around the world to share information about prevention and clinical management strategies for pneumococcus, meningococcus, and Hib. In the same month, the Alliance for Case Studies in Global Health published a collection of best practices and lessons learned from health initiatives worldwide in its new book Case Studies in Global Health. Several case studies highlighted PATH projects, including PATH’s vaccine development partnership with Intercell AG, which has advanced a pneumococcal common protein vaccine candidate from preclinical research into early-stage clinical trials.

In a related story, the Johns Hopkins Bloomberg School of Public Health, a frequent collaborator with PATH, recently launched the International Vaccine Access Center (IVAC) to accelerate global access to vaccines through the development and implementation of evidence-based policies. As part of this new initiative, the Bloomberg School will continue its work against pneumococcal disease and will build upon its previous experience running the PneumoADIP program, which helped speed the uptake of pneumococcal conjugate vaccines in low-resource countries with support from the GAVI Alliance. One of several new projects going forward under IVAC is PneumoACTION—a web-based resource for decision-making and advocacy on pneumococcal disease.

PATH recently signed an agreement with the University of Kansas Center for Research (KUCR) to support the advancement of vaccine candidates across PATH’s vaccine development portfolio. The KUCR project, under the direction of Dr. Russ Middaugh, will systematically determine how various PATH-supported vaccine candidates behave under a variety of formulation conditions. The goal of the partnership is to characterize vaccine antigens and identify conditions under which their stability may be enhanced. KUCR has already started working with PATH's pneumococcal vaccine project and will likely work with other PATH vaccine projects in the future.

Scientific advisory boards, comprised of key experts in their fields, guide several of PATH’s vaccine development projects. PATH invites these specialists to join the advisory boards to provide strategic input on technology evaluation, selection, and prioritization for project support. Based, in part, on guidance from these experts, PATH collaborates with private- and public-sector partners to advance the development of the most promising vaccine candidates. Board members play a key role in this process, meeting regularly to discuss the vaccine portfolio, address technical issues, review data and progress made to date, and provide recommendations. These experts play an important role in supporting the creation of robust portfolios that bring lifesaving vaccines one step closer to reality. PATH currently has scientific advisory boards for its enteric vaccine project, pneumococcal vaccine project, and influenza vaccine project.

7th International Symposium on Pneumococci and Pneumococcal Diseases, Tel Aviv, Israel, March 14 to 18. This conference brings together top researchers and clinicians from around the world to discuss the latest highlights and scientific achievements related to pneumococci and pneumococcal diseases, including topics related to epidemiology, vaccines, and treatment. PATH is pleased to help sponsor this seminal conference and will host an exhibition booth. Dr. Alderson will also deliver a presentation on PATH’s pneumococcal vaccine project as part of a conference luncheon event on March 17.

Modern Mucosal Vaccines, Adjuvants & Microbicides, Dublin, Ireland, April 28 to 30. This annual conference provides participants with an opportunity to discuss topics related to mucosal environment and immunity. This year’s conference includes sessions on lessons learned from existing mucosal vaccines and microbicides, development approaches, route of immunization considerations, and mucosal vaccines currently in development. Dr. Richard Walker, director of PATH’s enteric vaccine project, will present on challenges and opportunities for enteric vaccines for the developing world.

World Water Day 2010: Clean Water for a Healthy World, Global, March 22. This annual internationally-recognized day, sponsored by United Nations Water, focuses on topics related to freshwater. This year’s World Water Day highlights water quality and its importance in relation to water management and the amount of globally available water. Organizations and individuals around the world are organizing various events in celebration, which are listed on the World Water Day website. A number of activities will focus on water and sanitation. PATH will work with partners to highlight the important linkages between water, sanitation, and diarrheal disease—and the package of solutions necessary to address the world’s second leading killer of children.

PATH’s vaccine development program is working to accelerate the development of innovative, safe, effective, and affordable vaccines against the leading causes of childhood deaths in the developing world, pneumonia (pneumococcal disease) and diarrheal disease (rotavirus, Shigella, and enterotoxigenic Escherichia coli), as well as new influenza vaccines for the global population. PATH is also partnering on vaccine development through its Malaria Vaccine Initiative and the Meningitis Vaccine Program. Additionally, PATH works to ensure the worldwide availability of vaccines through its Vaccine Access and Delivery Program. The work of the vaccine development program is currently supported by grants from the Bill & Melinda Gates Foundation and the US Centers for Disease Control and Prevention. Some projects within the vaccine development program are funded by PATH Vaccine Solutions.

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